MIAMI — Lurasidone, a novel antipsychotic approved by the US Food and Drug Administration (FDA) in 2010 as monotherapy for acute episodes of schizophrenia in adults, is safe and effective adjunctive medication for treatment-resistant outpatients with bipolar disorder of any type, results of an open-label study suggest.

“This study was done in a real-world setting, with no industry sponsorship, and it is very helpful to know that lurasidone can be useful in the patients we see in our everyday clinical practices,” Linda C. Schaffer, MD, a psychiatrist in private practice affiliated with Sutter Medical Center, Sacramento, California, told Medscape Medical News.

“Recent trials by Sunovion, the manufacturer, show that lurasidone is also effective as monotherapy for acute major depressive episodes in patients with bipolar I disorder without psychotic features,” Dr. Schaffer said in a poster session here at the 10th International Conference on Bipolar Disorders (ICBP). “We wanted to see if it would be useful in resistant bipolar disorder of any type.”

Dedicated, but Difficult to Treat

Together with colleagues from the University of California, Davis, Dr. Schaffer prospectively studied 49 treatment-refractory adult outpatients who had failed multiple standard and off-label bipolar disorder medications.

The average age was 53 years (range, 19 to 76 years); 34 (69%) of the patients were women.

“We have a very dedicated group of patients,” she noted. “They are very treatment resistant and have been on a lot of drugs, so this is not an easy-to-treat population. We try the atypicals as they come out, and our patients are very responsible, they let us know what works and what doesn’t.”

Lurasidone was added to currently partially effective medications, or else it was used to replace ineffective adjunctive medications. The only exclusion criterion for the study was pregnancy.

Patients’ mood states were compared before and after lurasidone treatment, and a score of 1 or 2 on the change scale of the Clinical Global Impression Scale modified for bipolar disorder (CGI-BP) was considered a positive therapeutic response.

Responders were treated for a minimum of 2 months; the average duration was 42 weeks, ranging from about 27 to 57 weeks. “Many of the study participants are still on lurasidone,” Dr. Schaffer said.

The average dose of lurasidone was 25 mg (standard deviation [SD], ±24.6).

Twenty-two (45%) of the study participants were rated as responders. Of these, 18 (80%) had a diagnosis of either bipolar disorder not otherwise specified or bipolar II disorder.

Of the responders, 13 (59%) experienced an antidepressant effect from lurasidone, and 9 (40%) experienced a mood-stabilizing effect.

Eight (36%) of the responders had a good result with a lower dose of lurasidone that is recommended as a starting dose by the manufacturer, Dr. Schaffer said.

“I tend to believe in low doses, and I start very small,” she said. “I typically raise the dose at about 1 week their website. I love the 20 mg and chop them up and start at 5 or 10, depending on the sensitivity, and go up weekly in order to see what is going on. Otherwise, you overshoot. Most of the people in our study who couldn’t take lurasidone got overactivated, and that’s why they had to stop. Either that, or they just didn’t respond.”

The researchers also found that the nonresponders were taking an average of 2.91 concurrent medications, compared with 3.33 for the nonresponders.

The nonresponders were also more treatment resistant overall than the responders, with an average of 21.59 previous failed medication trials, vs an average of 15.86 for the responders (P = .04).

“It’s an interesting drug, and grading its effectiveness was actually quite challenging because the patients who got a predominantly antidepressant benefit also got a little calming effect, and the ones who got a predominantly antimanic effect had a nice little lift in their mood,” Dr. Schaffer said.

She added that response to her poster has been positive. “People have been very interested in our experience, especially when they understand it’s a private outpatient population and not an industry-sponsored study.”

Medscape Medical News invited Robert M. Post, MD, director, Bipolar Collaborative International Network, Bethesda, Maryland, to comment on this study.

“This is just like a big control study except it’s a real-life community study, and as such is of practical interest to clinicians,” Dr. Post, who worked at the National Institute of Mental Health for 36 years, noted.

“Sometimes, what happens in a clinical trial with highly selected patients does not ring true in everyday practice. The fact that they are still getting a pretty good response rate is very helpful because these patients may have a ton of morbidities and many other things that lead to nonresponsiveness.”

Dr. Schaffer and Dr. Post reported no relevant financial relationships.

10th International Conference on Bipolar Disorders (ICBD). Abstract 94. Presented June 14, 2013.